MADECA DERMA MASK- glycerin, niacinamide patch 
Dongkook Pharmaceutical Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: Glycerin 5.0%, Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Citrus Paradisi (Grapefruit) Fruit Extract, Alcohol, Xanthan Gum, PEG-60 Hydrogenated Castor Oil, Centella Asiatica Extract, Carbomer, Ethylhexylglycerin, Adenosine, Potassium Hydroxide, Panthenol, Allantoin, Asiaticoside, Asiatic Acid, Madecassic Acid, Fucose, Caprylic/Capric Triglyceride, Saccharide Isomerate, Glycosphingolipids, Glycolipids, Xylitylglucoside, Propanediol, Anhydroxylitol, Pseudoalteromonas Ferment Extract, Xylitol, Alaria Esculenta Extract, Magnesium Aspartate, Zinc Gluconate, Glucose, Asparagus Officinalis Stem Extract, Caprylyl Glycol, Glutamic Acid, Glycoproteins, Sodium Benzoate, Potassium Sorbate, Gluconolactone, Calcium Gluconate, Copper Gluconate, Valine, Threonine, Palmitoyl Tripeptide-5, Citric Acid, Sodium Citrate, Sodium Metabisulfite, Proline, Alanine, Serine, Sodium Phosphate, Sodium Metabisulfite, Acetyl Hexapeptide-8, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Fragrance

PURPOSE

Purpose: Skin protectant

WARNINGS

Warnings: 1. Avoid contact with eyes. In case of contact with eyes, rinse immediately with water. 2. Use with caution if you are highly sensitive to any bandages or wet compresses. 3. Do not use the product on an open skin wound or on areas of eczema or infection. 4. If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above. 5. Storage and handling instructions 1) Apply immediately after removing it from packaging because it can dry up. 2) Keep out of reach of children. 3) Avoid exposure to high or low temperatures or sun.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage:

1. After cleansing your face, apply skin toner.

2. Take the product out of the package and adhere it evenly over your face avoiding the eye and mouth area.

3. Remove it after 10-20 minutes. Using your fingers, gently pat any remaining product into the skin until thoroughly absorbed.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use immediately after opening.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MADECA DERMA MASK 
glycerin, niacinamide patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70541-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 g  in 10 
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 g  in 10 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70541-010-0110 in 1 CARTON; Type 0: Not a Combination Product02/01/201602/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/201602/01/2019
Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)
Registrant - Dongkook Pharmaceutical Co., Ltd. (688003495)
Establishment
NameAddressID/FEIBusiness Operations
Dongkook Pharmaceutical Co., Ltd.688003495manufacture(70541-010)

Revised: 12/2018
 
Dongkook Pharmaceutical Co., Ltd.